Trial information
A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
Status: Recruiting
Protocol number: NN19866
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind, multiple ascending dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 following intravenous infusion in Alzheimer Disease
Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 80.
Study phase: I
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety study
Condition: Alzheimer Disease
Intervention type: Drug
Intervention name: R1450
Primary outcome: 1. AEs, laboratory parameters, vital signs. Time frame: Throughout study
2. Pharmacokinetic parameters of R1450 in plasma Time frame: Throughout study
Key secondary outcomes: 1. CSF biomarkers, clinical efficacy parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, 50-90 years of age;
- diagnosis of probable Alzheimer Disease, with symptoms >=1 year prior to screening;
- meets DSM-IV criteria for Alzheimer-type dementia;
- stabilised on approved medications for treatment of Alzheimer Disease for >=4 months prior to baseline.
Exclusion criteria:
- active major depressive disorder, or a history of bipolar disorder;
- history of schizophrenia;
- concurrent participation in a non-pharmacological trial with a key objective of improving cognition;
- prior randomisation in any R1450 trial.
Gender: Males or Females
Age limits: Min: 50 Years Max: 90 Years
Accepts healthy volunteers: No
Anticipated start date: December, 2006
Trial registration date: 10/17/2006
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Denmark
Israel
Netherlands
Sweden
United Kingdom
- Blackpool
- Glasgow
- Penarth
- Southampton
- Swindon
